Cl II elekta iGUIDE System

Company: Elekta Inc.
Date of Enforcement Report 6/1/2016
Class lI:

PRODUCT

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Recall Number Z-1705-2016

REASON
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data..

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 5/12/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20

DISTRIBUTION
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.